- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07067320
- Original Trial
Bibliotherapy Combined With Games to Reduce Fear of the Dark in Young Children
July 14, 2025 updated by: Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche
Efficacy of Bibliotherapy Combined With Games to Reduce Fear of the Dark in Young Children: Results From a Clinical Trial
Intense fear of the dark is a common issue among children, which can interfere with their daily functioning at family, social, and academic levels.
This study aims to analyse the effectiveness of a psychotherapeutic intervention based on bibliotherapy combined with play to overcome the fear of the dark in children between 4 and 8 years old.
A total of 38 children participated, who were assigned to the experimental and control conditions on the waiting list.
The bibliotherapy intervention in the experimental condition involved reading a book and playing the games proposed in each chapter.
The intervention was applied by parents at home with their children (during 4-5 weeks) and contained cognitive-behavioural techniques, such as gradual in vivo exposure, relaxation techniques, modelling and positive reinforcement, among others.
It is expected that children's nighttime fears will decrease significantly and there will be significant improvements in nighttime behaviour.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alicante
-
Elche, Alicante, Spain, 03202
- Universidad Miguel Hernández
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between 4 and 8 years old
- Obtaining a score of 32 or higher on the Parent Version of the Nighttime Fears Scale (NFS-P; Orgilés et al., 2024)
Exclusion Criteria:
- Not being within the established age range
- Scoring less than 31on the Parent Version of the Nighttime Fears Scale (NFS-P; Orgilés et al., 2024)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group receiving bibliotherapeutic intervention
Bibliotherapy combined with games to overcome fear of the dark
|
Bibliotherapy combined with games, applied by parents at home.
Treatment based on cognitive-behavioural techniques.
Duration: 4-5 weeks.
Experimental group recived this bibliotherapeutic intervention.
|
|
No Intervention: Waiting list control group (receiving intervention at the end of treatment with experimental group)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nighttime fears
Time Frame: Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
|
Parent Version of the Nighttime Fears Scale (NFS-P): The NFS-P assesses school-age children's level of fear at night, as reported by their parents.
It contains four subscales: fear of nighttime features and distressing experiences (stimuli associated with darkness), fear of loss or separation from family (loss or non-presence of attachment figures and other family members), fear of imaginary stimuli (non-factual stimuli that may be likely to cause fear) and fear of real stimuli.
It consists of 21 items that ask about night-time situations that are likely to cause fear in children.
These items have a 5-point response scale, ranging from 0 (Not at all) to 4 (Very much).
The higher the score, the greater the intensity of night-time fears.
|
Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nighttime functioning
Time Frame: From enrollment to the end of treatment at 4-5 weeks
|
On a daily basis, families completed a log on different behaviours of their children during the night.
Variables included: number of minutes it takes to go to bed, number of minutes it takes to fall asleep, avoidance behaviours, need for company to fall asleep, presence of security light, number of night-time calls to parents' bed, number of night-time visits to parents' bed, whether they sleep in their bed all night and, finally, whether they made use of the book and/or games.
|
From enrollment to the end of treatment at 4-5 weeks
|
|
Nighttime functioning
Time Frame: Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
|
Nighttime Behaviors Questionnaire for Children - Parent-reported (NBQC-P): The NBQC-P assesses, through parents' responses, children's usual behaviours before going to sleep and during the night.
It consists of three subscales: need for company, problems during the night and problems going to sleep.
It contains 13 items, with a Likert-type response scale from 0 (Never or almost never) to 4 (Always or almost always).
A higher score on each dimension implies a greater need for company to sleep, greater resistance before going to bed and greater interference with night-time awakenings.
|
Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
|
|
Adaptive nocturnal behaviours
Time Frame: Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
|
What I Can Do At Night - Parent Form (WICDAN-P): It assesses, through parents, children's ability to perform adaptive night-time behaviours during the last week.
The scale consists of 11 items, with a 3-point response scale (0 = No; 1 = Yes, with difficulty or hesitation; 2 = Yes, with ease).
The total score of the questionnaire is from 0 to 22.
A higher score indicates adaptive night-time behaviour.
|
Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2023
Primary Completion (Actual)
October 18, 2024
Study Completion (Actual)
October 18, 2024
Study Registration Dates
First Submitted
June 11, 2025
First Submitted That Met QC Criteria
July 14, 2025
First Posted (Actual)
July 16, 2025
Study Record Updates
Last Update Posted (Actual)
July 16, 2025
Last Update Submitted That Met QC Criteria
July 14, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- DPS.MOA.210423
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be shared due to the small sample size and the sensitive nature of children's psychological data, with the primary aim of ensuring confidentiality and anonymity.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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